跳转到主要内容

定量药理学

Pharmacometrics services

Pharmacometrics Services

Pharmacometrics modeling increases our understanding of key factors by leveraging quantitative methods. 

Pharmacometrics services use mathematical modeling to quantify interactions between drugs and patients, and it helps optimize drug development and regulatory decisions. Understanding a drug’s benefit-risk profile in a target patient population is key for a successful drug. Pharmacometrics combines various modeling approaches to integrate relevant data that enable the characterization of the efficacy, safety, and biomarker responses of a new drug. The specific applications of pharmacometrics models will evolve during the course of development, and typical questions that they help answer are:  

  • Selecting doses and dosing regimens for future clinical studies  
  • Identification of patient factors that impact safety or efficacy  
  • Optimizing clinical study designs for optimal information content  
  • Developing, selecting, and optimizing drug formulation  

Choose Certara: World’s Largest Pharmacometrics Team 

With over 120+ pharmacometricians, the Certara Pharmacometrics team designs and implements MIDD strategies for all types of drug development programs, regardless of therapeutic area, drug modality, and development phase. 

优化推进/不推进决策 

Certara 提供了高质量的,符合监管要求的药代动力学和药效动力学 (PK/PD) 分析和监管申报文件包的建模。 

我们的定量药理学家支持: 

  • 针对新药审批的临床前和临床研究分析 
  • 产品延伸 
  • 许可引进选项 
  • 产品组合决策 

凭借全球最大的 PhD、PharmD 和 MD 顾问团队,我们利用量化方法建立了一个包含药物发现、临床前、早期临床、文献和竞争对手数据的综合知识库,可用于优化决策,包括将促进商业化活动的“推进/不推进”决策。 

这些分析还可以为批准后的研究决策提供信息。 

Pharmacometrics modeling services
Pharmacometrics modeling services

量化方法的优势 

在过去几年由美国 FDA 批准的所有新药中,有 90% 以上在其开发项目中使用了定量药理学,大多数利用了 Certara 的服务或技术。 

  • 在药物开发的各个阶段,通过量化框架制定以数据为驱动的决策 
  • 设计更安全、更有针对性的、更高效的试验 
  • 第一时间为合适的患者选择合适的剂量 
  • 最大程度提供商业化取得成功的可能性 

建模的好坏取决于您的数据 

Want to ensure the highest quality dataset for your analysis?  Certara’s data programmers are experts in using SAS to code pharmacokinetic and pharmacodynamic (PK/PD) datasets. 

  • 我们的数据编程人员为我们的项目创建数据集 
  • 我们可以创建更高质量的数据集,需要的 QC 周期更少。 
  • 我们可以减少数据库锁定和执行非房室分析 (NCA)、探索性分析或 PK/PD 建模之间的时间 
Pharmacometrics modeling services

与专家见面

Rik de Greef

Rik de Greef

Senior Vice President, Global Lead, Quantitative Science Services


Stephen Duffull

Senior Scientific Advisor, Quantitative Science Services


Matt Zierhut

Vice President, MBMA Capability Lead

JF Marier

Senior Vice President, Canada Region Lead, Quantitative Science Services

Adekemi Taylor

Vice President, QSS-US-1 Region Lead, Quantitative Science Services 


Mirjam Trame

Vice President, QSS-US-2 Region Lead, Quantitative Science Services 


Amy Cheung

Vice President, Europe/APAC Region Lead, Quantitative Science

Paul Diderichsen

Vice President, Europe/Africa Region Lead, Quantitative Science Services

Book a Meeting with our Pharmacometricians

资源

沪ICP备2022021526号

Powered by Translations.com GlobalLink Web Software